Local Regulatory Affairs Head
Boehringer Ingelheim
Currently we are looking for a person for the position: Local Regulatory Affairs Head
Place of work: Warsaw
**Tasks and responsibilities:**
+ Processes (as allocated to the individual team members)
+ Provide input to Global RA, Local and ROPU RA concepts/strategies/projects
+ Regulatory Intelligence: Foster close relationships with relevant Authorities and other key stakeholders
+ Communication & impact assessment on new requirements
+ Maintain allocated databases
+ Share best practices within the OPU
+ Compliance
+ Ensure adherence to BI and international compliance rules as well as to local legislations in allocated areas of Regulatory Affairs
+ Constant tracking of all compliance parameters for allocated products and processes (KPls)
+ Marketing Support
+ Preparation of short version of Summary of Product Characteristics
+ Responsibility for RA budget planning and spending
+ Ensure all Non-Compliances are reported and followed up
+ Managing local Regulatory Affairs team consisted of two experts
**About our future employee:**
+ University scientific degree
+ Knowledge of local and international regulatory affairs regulation
+ Relevant experience in pharmaceutical industry/CRO is an asset
+ Good command of English language
+ Organisational and communication skills
+ Proactive attitude
+ Team- and networker
+ Thoroughness
+ Strategic thinking
+ Ability to judge a case
+ Ability to lead & learn
**What we offer:**
In this position, we offer employment based on a contract of employment, great possibilities of development and a bonus system.
**Additionally, we offer:**
+ Remuneration adequate to the level of experience and competence
+ Independence in daily activities
+ Company car, phone, laptop
+ Opportunities for improvement and professional development
+ Package of non-salary benefits (medical care, life insurance, Multisport card, My Benefit cafeteria)\#LI-DNI
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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